MP: UK should seek licenses for off patent drugs in new indications

UK Gov should seek licenses for off-patent drugs in new indications says MP

24-Jul-2014 - The UK Government should seek licenses to use off-patent drugs in new indications according to MPs who say there is no incentive for pharma firms to apply for such approvals after a product goes generic.

Advair sales fell 19% in the US for the quarter, year-on-year

GSK's declining Advair sales to be propped by respiratory portfolio

24-Jul-2014 - GlaxoSmithKline has issued upbeat guidance despite a 12% fall in sales of its blockbuster asthma and COPD drug Advair, as new products enter the respiratory drug market.

Acting up: the FDA recommends doctors role-play to see if drug names are confusing. (Picture credit: ABC Media)

Is your drug name ok? Run a role-play, says FDA

24-Jul-2014 - Industry insiders have criticised new draft US Food and Drug Administration (FDA) guidance on choosing proprietary drug names, saying simulation studies involving doctors, nurses and pharmacists are time-consuming and unhelpful.

Ipca halts API shipments to US following 483 at Indian plant

Ipca halts API shipments to US following 483 at Indian plant

24-Jul-2014 - Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.

Italy to look at drug pricing during EU presidency

Italy to look at drug pricing during EU presidency

24-Jul-2014 - Italian health Minister Beatrice Lorenzin will focus on making drug National price regulations and decisions more trasnparent during the country's presidency of the EU.

Onyx contracted for API R&D and manufacturing by UK cancer charity

Onyx contracted for API R&D and manufacturing by UK cancer charity

23-Jul-2014 - Onyx Scientific has been contracted to develop and manufacture APIs for clinical trials by charitable group Cancer Research UK.

MonosolRx finds new licensee for oral film delivered ondansetron

MonosolRx finds new licensee for oral film delivered ondansetron

23-Jul-2014 - MonosolRx has found a new US licensee for its oral film ondansetron product, Zuplenz, signing up Galena BioPharma nearly four years after previous partner Strativa handed the drug back.

Generics: change in pill shape makes patients 66% more likely to quit

Generics: change in pill shape makes patients 66% more likely to quit

23-Jul-2014 - Switching patients to generic pills of a different shape and colour increases the chances they will end their course of medicine early, according to research.

Harding St, Indianapolis facility to have its manufacturing processes 're-balanced'

Lilly swaps dry powders for insulin at Indiana site in post-patent shake-up

23-Jul-2014 - Patent expiration and a large molecule pipeline has prompted Eli Lilly to repurpose a solid oral dose plant in Indiana.

ADHD API sales up, specialty opiates down at Johnson Matthey in Q1

ADHD API sales up, specialty opiates down at Johnson Matthey in Q1

23-Jul-2014 - Johnson Matthey’s API business had a mixed fiscal Q1 with gains made in ADHD ingredients and bulk opiates being accompanied by a decline in revenue from specialty opiates.

The ICH has reached the adoption stage for a new guideline on elemental impurities.

European Pharmacopoeia plans revisions of elemental impurities guideline

23-Jul-2014 - As the International Conference on Harmonisation (ICH) signs off on a new tripartite guideline related to elemental impurities, the European Pharmacopoeia Commission will revise its texts to ensure consistency. 

Sterile injectables M&A could indicate return to in-house, says F&S

Sterile injectables M&A could indicate return to in-house production

22-Jul-2014 - Drugmakers are bringing sterile injectables capacity back in-house according to a Frost & Sullivan analyst, who says industry risk aversion is the key driver.

Jay-Z and Scarface: pharma staff’s anonymous Wikipedia interests

Jay-Z and Scarface: pharma staff’s anonymous Wikipedia interests

22-Jul-2014 - Big pharma employees are among the brightest minds in the world, and data released yesterday on their Wikipedia use shows their interests spread beyond drug development into lighter fare.

New Uppsalite excipient cheaper than mesoporus silica for formulations

New nanotech excipient offers cheaper solubility option say scientists

22-Jul-2014 - Scientists in Sweden have developed a magnesium carbonate-based excipient they claim is a low-cost nanotech alternative to silica for drugmakers struggling to formulate insoluble APIs.

As far as job cuts are concerned, the company will see its R&D staff cut by 33%

Allergan further fends off Valeant with 1,500 job cuts, M&A projections

22-Jul-2014 - Botox maker Allergan announced sales and earnings per share growth above the high end of its expectations, but it will cut 1,500 jobs, or about 13% of its workforce as it continues to avoid a $54bn hostile takeover bid from Valeant Pharmaceuticals.

CSO offices in Cork, Ireland

Drug ingredients were key to Ireland's manufacturing growth in 2013 says CSO

21-Jul-2014 - Basic pharmaceuticals including APIs became even more important revenue generators for Ireland in 2013 according to new data released by the Central Statistics Office (CSO).

PhRMA supports Customs drug destruction, responds to critics of law

PhRMA supports Customs drug destruction, responds to critics of law

21-Jul-2014 - PhRMA (Pharmaceutical Research and Manufacturers of America) has warned that illegal medicines rejected at the US border will continue to be resubmitted for importation unless a proposed law allows their destruction.

Role changes for AbbVie and Shire CEOs after merger

Role changes for AbbVie and Shire CEOs after merger

21-Jul-2014 - It has been a hectic few days for the chief executives of AbbVie and Shire since their companies agreed a £32bn ($53bn) merger on Friday.

Glenmark to build first US manufacturing plant

Glenmark to build first US manufacturing plant

21-Jul-2014 - India-based Glenmark Pharmaceuticals has announced plans to set up a new oral solid dosage manufacturing facility in North Carolina. 

Pan American Health Organisation building in Washington DC, US

US FDA looks to increase cooperation with Latin American counterparts

21-Jul-2014 - The US FDA is looking to up its cooperative agreements with PAHO (Pan American Health Organization) as part of an effort that could bring as much as $10m over five years to the Latin American version of the WHO (World Health Organization).